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UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
This study is currently recruiting participants.
Verified by Kendle International, May 2008
Sponsors and Collaborators: Kendle International
UCB
Information provided by: Kendle International
ClinicalTrials.gov Identifier: NCT00345475
  Purpose

This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra (levetiracetam) and other UCB antiepileptic drugs (AED) at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra and other UCB AEDs in order to determine if there is a potential increase in the risk of major birth defects compared to rates from women in the general US population.

The objectives of the UCB AED Pregnancy Registry are:

  • To prospectively collect data concerning 1) exposure to Keppra and other UCB AEDs during pregnancy, 2) potential confounding factors, 3) outcome of pregnancy, and 4) long-term pediatric outcome
  • To review reported cases of possible birth defects
  • To estimate the risk of birth defects occurring in live-born offspring of women exposed to Keppra and other UCB AEDs during pregnancy

This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by Kendle International, Inc. The scientific conduct and analysis of the Registry is overseen by an Expert Panel consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).


Condition Phase
Birth Defects
Pregnancy Complications
Epilepsy
Seizures
Phase IV

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Levetiracetam
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective

Further study details as provided by Kendle International:

Estimated Enrollment: 300
Study Start Date: December 2004
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The subjects must meet the following criteria for registration:

  • Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
  • Exposure to Keppra and other UCB AEDs on or after the first day of the patient's last menstrual period (verified by date or gestational age of exposure)
  • For patient-initiated enrollments, provide verbal or written consent to participate in the Registry
  • For patient-initiated enrollments, provide contact information for herself, her HCP, and the infant's HCP (as applicable)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345475

Contacts
Contact: Angie Graves, MBA 888-537-7734 registries@kendle.com
Contact: Kathryn Bronstein, PhD, RN 770.970.8579 kathryn.bronstein@ucb-group.com

Locations
United States, North Carolina
Kendle International, Inc. Recruiting
Wilmington, North Carolina, United States, 28405
Contact: Angie Graves, MBA     888-537-7734     registries@kendle.com    
Contact: Kathryn Bronstein, PhD, RN     770.970.8579     kathryn.bronstein@ucb-group.com    
Sponsors and Collaborators
Kendle International
UCB
Investigators
Principal Investigator: Deborah Covington, DrPH Kendle International, Inc.
Study Director: Kathryn Bronstein, PhD, RN UCB
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Kendle International, Inc. ( Deborah L. Covington, DrPH )
Study ID Numbers: KEP-1
Study First Received: June 26, 2006
Last Updated: May 9, 2008
ClinicalTrials.gov Identifier: NCT00345475  
Health Authority: United States: Institutional Review Board

Keywords provided by Kendle International:
Birth Defects
Epilepsy
High Risk Pregnancy

Study placed in the following topic categories:
Pregnancy Complications
Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases
Congenital Abnormalities

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009